Physicians use a variety of instruments to deliver a medicament to different cavities in a mammalian body. A typical instrument used to deliver a medicament is a syringe with a needle or a cartridge. Needles and cartridges can be made using a metal or a non-metal material. One such example of a mammalian cavity is the cavity between the gums and teeth. Dentists routinely deliver medicaments to this cavity in an effort to treat periodontal disease.
Periodontal disease is a term used to describe dental conditions associated with gingivitis or periodontitis. Gingivitis is an inflammation of the gingiva, commonly known as gums, that is commonly associated with poor oral hygiene and/or the hormonal state of the patient. If left untreated, gingivitis may develop into periodontitis.
Periodontitis is a bacterial disease in which the infection has progressed to involve the oral tissues that retain the teeth in the jawbone. With this disease the gums become red and inflamed. This condition, if untreated, results in damage to the ligaments and bone holding the teeth in place, and formation of pockets around the teeth. As the pockets become deeper, teeth loosen, to a point where they may fall out. The severity of periodontitis is determined by dentists, and other dental practitioners, by measuring the depth of these pockets and reviewing x-rays of the teeth and jawbone.
Periodontal disease involves a different treatment protocol than other oral diseases. While many oral diseases can be treated with proper hygiene, fluoride, pastes, washes and rinses, periodontal disease is often more refractile to treatment. This is because of differences between the oral and periodontal cavities. The bulk of the oral cavity is essentially an aerobic environment, constantly perfused by saliva. In contrast, the periodontal cavity is more anaerobic, and is perfused by plasma filtrate, known as “crevicular fluid”. The growth of microorganisms within the periodontal cavity microenvironment may cause periodontal disease. As the disease progresses, the periodontal microenvironment becomes more anaerobic, and the flow of crevicular fluid increases.
Efforts to treat periodontal disease have met with limited degrees of success. This is because the site of the bacterial infections in the periodontal cavity are largely inaccessible to agents present in the oral cavity as well as agents provided to the oral cavity, such as mouthwashes, rinses and the like. Moreover, the increased outflow of crevicular fluid that accompanies periodontal disease inhibits therapeutic agents placed into the oral cavity from entering the pockets.
Oral systemic administration of antibiotics has been shown to be a useful method of controlling subgingival flora. However, because of side effects, such as those of the digestive system and concerns over bacterial resistance, oral systemic administration has had only limited use in treating periodontal disease. Oral systemic therapy also requires frequent dosing, so patient compliance is frequently a problem.
Efforts have focused on delivering therapeutic agents directly to these pockets, in some cases, in a controlled release formulation. In general, administration of agents directly to the pocket permits higher local drug concentrations that can be achieved by systemic administration while simultaneously avoiding the GI and other potential side effects of the higher oral systemic dosages needed.
U.S. Pat. No. 4,175,326 to Goodson discloses the use of a drug-filled polymer hollow fiber. The disclosed delivery system is tied around a tooth and gently pressed below the margin of the gingiva so that it resides in the periodontal pocket, and can deliver tetracycline for a prolonged period, such as a week or more. U.S. Pat. No. 5,236,355 (Brizzolara et al) describes a tip for delivery of medicament to a periodontal pocket. U.S. Pat. No. 6,682,348 describes an apparatus comprising a tip capable of delivering material to a periodontal pocket. The tip described in this patent is not positionable to a specified retained angle nor extendable, thereby hindering positioning of the tip (frequently requiring twisting of the device, adding complexity and making it harder to handle by the user) so that the device is less than optimal and is less efficient for the delivery of material to the desired site of action. U.S. Pat. No. 6,083,002 (Martin et al) and U.S. Pat. No. 4,575,375 (Kozam) describe dispensing cartridges for a liquid or semi-liquid compositions. U.S. Pat. No. 5,129,825 (Discko, Jr) describes a dental syringe and dispensing device. U.S. Pat. No. 5,112,307 (Haber et al) discloses a dental syringe having a medication filled capsule. U.S. Pat. No. 5,004,124 (Stefaniak et al) discloses a device for dispensing a fluid substance. U.S. Pat. No. 6,047,864 (Winkler) discloses an actuating device for dispensing a paste like material. U.S. Pat. No. 5,947,728 (Riebl et al) discloses a dental applicator. Each of the foregoing patents and patent applications (as well as any others mentioned in the present application) are incorporated herein in their entirety by reference except to the extent that the discussion in the present application explicitly states matter in contradiction to such reference or requires, implicitly, due to the context of the discussion in the present application, a different understanding. Furthermore, in the case of such conflicting language or construction, the explicit statements in the present application and the constructions impliedly required by the discussion in the present application shall govern over any contrary interpretation or construction in the otherwise incorporated reference.
There is thus a need for an apparatus that provides the flexibility to a user or a clinician to position the tip to efficiently deliver medicament and/or other materials to cavities within a human body. There is further a need for an apparatus that provides the flexibility of the user to position the tip of to efficiently and appropriately deliver substances to cavities, cracks, and crevices that are outside of the realm of medical applications.